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The examination gloves are to be worn by healthcare workers or similar personnel during work to prevent cross contamination between the user and the patient.

Nugard Nitril meet the requirement for examination glove described by the American Standard for Testing and Material ASTM D 3578 with the exception of ultimate elongation before aging. It is blue in color and prepowdered. Sizes available is from XS - XL

This is a 510(k) summary for a Nitrile Examination Glove, not a medical device involving AI or complex performance criteria that would necessitate a study with human readers, ground truth, or intricate statistical analysis. The acceptance criteria for this type of device are primarily based on material properties and basic performance as defined by industry standards.

Here's how to interpret the provided information in the context of the requested table and study details:

Acceptance Criteria and Device Performance for NUGARD Nitrile Examination Glove (K990841)

Biocompatibility tests: These were also carried out. The summary does not provide specific results but indicates the device meets the requirements. |
| ASTM D 512 | Meets requirements | (See above for Non-clinical tests) |
| Biocompatibility | Tests carried out | (See above for Non-clinical tests). The exact acceptance criteria for biocompatibility are not explicitly detailed here but are implied by the statement "Biocompatibility tests are carried out" and the overall conclusion that the product meets requirements. |
| Prevent cross-contamination | Intended use | This is the intended use, and meeting the physical and barrier properties of ASTM D3578 and D512 supports this claim. No specific "study" is described for directly proving prevention of cross-contamination beyond adherence to the material standards. This is generally assumed for examination gloves that meet relevant standards. |

Detailed Study Information (Based on provided text):

As this is a submission for an examination glove, the "study" described is primarily a series of non-clinical laboratory tests to confirm material properties and safety, rather than a clinical trial or an AI performance study.

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for the ASTM D3578, ASTM D512, or biocompatibility tests.
   • Data Provenance: The tests were conducted by the manufacturer, Terang Nusa Sdn Bhd, based in Malaysia. The report does not specify the country of origin of the raw data (e.g., where the gloves were manufactured or where the tests were physically performed, beyond the submitter's location). These are non-clinical (laboratory) tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable for this type of device. "Ground truth" in the context of examination gloves refers to whether the glove physically meets the specified ASTM standards for properties like tensile strength, elongation, barrier integrity (pinholes), biocompatibility, etc. These are objective measurements performed by laboratory technicians/engineers following established protocols, not subjective expert assessment of images or clinical conditions.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in subjective assessments (e.g., by radiologists or clinicians) when establishing ground truth for AI algorithms or clinical trials. The tests for an examination glove are objective measurements against a standard.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This question is not applicable. This device is a physical examination glove, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study, human readers, or AI assistance is involved.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device's performance is adherence to established industry standards and specifications (ASTM D3578, ASTM D512) and confirmation through objective laboratory measurements for physical properties, performance, and biocompatibility.

7. The sample size for the training set:

   • This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • This question is not applicable. There is no "training set" or corresponding ground truth for this device.

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